NCT06865794

Brief Summary

The primary objective of QUALIPLAST is to evaluate the impact of plastic and aesthetic surgery interventions on patients' self-esteem. While the demand for these procedures is steadily increasing worldwide, patients' motivations often extend beyond purely aesthetic concerns, encompassing significant psychological and emotional expectations. However, despite the growing popularity of these interventions, scientific literature remains limited when it comes to the systematic and long-term evaluation of their effects on patients' self-esteem and overall well-being. The majority of existing studies focus on short-term outcomes or functional and physical aspects, often overlooking the psychological and emotional dimensions that play a crucial role in post-operative satisfaction. Furthermore, much research is limited to specific procedures, without adopting a comprehensive approach to plastic and aesthetic surgery. This lack of robust and generalisable data hinders a full understanding of how these interventions influence self-esteem across different types of surgeries and patient profiles. QUALIPLAST stands out due to its multicentric, prospective, and large-scale nature, involving a wide range of procedures and collecting longitudinal data before the intervention, as well as at 3 and 12 months post-operatively. It will allow for the observation of self-esteem changes over time, providing a more complete and nuanced understanding of the effects of surgery. This project relies on standardized and validated measurement tools, such as the Rosenberg Self-Esteem Scale, to ensure the reliability and comparability of the results. By addressing the current gaps in the literature, QUALIPLAST aims not only to enrich scientific knowledge in this field but also to provide valuable insights for healthcare professionals to improve patient care and tailor clinical practices based on the identified psychological needs.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Apr 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Apr 2025Oct 2027

First Submitted

Initial submission to the registry

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2027

Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

2.5 years

First QC Date

March 4, 2025

Last Update Submit

March 12, 2025

Conditions

Keywords

plastic surgerycosmetic surgeryaesthetic surgery

Outcome Measures

Primary Outcomes (1)

  • Self-esteem score assessed by the Rosenberg self-esteem scale

    Self-esteem score assessed by the Rosenberg self-esteem scale

    Pre-operatively, at 3 and 12 months post-op

Study Arms (15)

Breast augmentation

Adult female patient undergoing breast augmentation for aesthetic reason

Other: Questionnaire and Physical Exam

Breast reduction

Adult female patient undergoing breast reduction for aesthetic reason

Other: Questionnaire and Physical Exam

Mastopexy

Adult female patient undergoing Mastopexy (Breast lift) for aesthetic reason

Other: Questionnaire and Physical Exam

Facelift

Adult patient undergoing facelift for aesthetic reason

Other: Questionnaire and Physical Exam

Otoplasty

Adult patient undergoing otoplasty for aesthetic reason

Other: Questionnaire and Physical Exam

Rhinoplasty

Adult patient undergoing rhinoplasty for aesthetic reason

Other: Questionnaire and Physical Exam

Blepharoplasty

Adult patient undergoing blepharoplasty for aesthetic reason

Other: Questionnaire and Physical Exam

Abdominoplasty

Adult patient undergoing abdominoplasty for aesthetic reason

Other: Questionnaire and Physical Exam

Brachioplasty

Adult patient undergoing brachioplasty for aesthetic reason

Other: Questionnaire and Physical Exam

Thigh lift

Adult patient undergoing thigh lift for aesthetic reason

Other: Questionnaire and Physical Exam

Liposuction

Adult patient undergoing liposuction for aesthetic reason

Other: Questionnaire and Physical Exam

Gender affirmation: breast augmentation

Adult patient undergoing breast augmentation gender affirmation surgery.

Other: Questionnaire and Physical Exam

Gender affirmation: facial feminisation

Adult patient undergoing facial feminisation gender affirmation surgery

Other: Questionnaire and Physical Exam

Gender affirmation : thoracoplasty

Adult patient undergoing thoracoplasty gender affirmation surgery

Other: Questionnaire and Physical Exam

Injectables/Fillers

Adult patient undergoing Botox or Hyaluronic acid injections for aesthetic reason

Other: Questionnaire and Physical Exam

Interventions

Rosenberg self-esteem scale pre-operatively, at 3 and 12 months post-op

Also known as: Rosenberg self-esteem scale
AbdominoplastyBlepharoplastyBrachioplastyBreast augmentationBreast reductionFaceliftGender affirmation : thoracoplastyGender affirmation: breast augmentationGender affirmation: facial feminisationInjectables/FillersLiposuctionMastopexyOtoplastyRhinoplastyThigh lift

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting a plastic surgeon for one of the following operations : * Breast augmentation * Breast reduction * Breast lift * Facelift * Otoplasty * Rhinoplasty * Blepharoplasty * Abdominoplasty * Brachioplasty * Cruroplasty * Liposuction * Gender affirmation: breast augmentation * Gender affirmation: Facial feminisation * Gender affirmation: Thoracoplasty * Botox / Hyaluronic acid

You may qualify if:

  • Patients consulting a plastic surgeon for one of the following operations:
  • Breast augmentation
  • Breast reduction
  • Breast lift
  • Facelift
  • Otoplasty
  • Rhinoplasty
  • Blepharoplasty
  • Abdominoplasty
  • Brachioplasty
  • Cruroplasty
  • Liposuction
  • Gender affirmation: breast augmentation
  • Gender affirmation: Facial feminisation
  • Gender affirmation: Thoracoplasty
  • +2 more criteria

You may not qualify if:

  • Pregnant, parturient or breastfeeding women
  • Minors
  • Persons deprived of their liberty by a judicial or administrative decision
  • Persons receiving psychiatric care
  • Persons admitted to a healthcare or social institution for purposes other than research
  • Adults under a legal protection measure (guardianship, curators)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Consultation Office of Dr. Emmanuel DELAY

Lyon, 69002, France

Location

Hospices Civils of Lyon - Croix-Rousse hospital

Lyon, 69004, France

Location

MeSH Terms

Interventions

Surveys and QuestionnairesRestraint, Physical

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Officials

  • Hugo Despert

    Hospices Civils of Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

April 15, 2025

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2027

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations